Comment sought on UK plans for “single research regulator”

The Academy of Medical Sciences is calling for comment on the government’s plans to consider giving responsibility for different aspects of medical research regulation to a “single research regulator.”

In March, the Labour government commissioned the Academy to undertake an independent review of the regulation and governance of UK medical research, following the Academy’s call to the leaders of the main political parties, ahead of the General Election, to “put medical research to work as the engine of Britain’s future prosperity.”

While “groundbreaking advances in medical science" offer the next UK government an unprecedented opportunity to reinvigorate the economy, enhance the productivity of the NHS and make public services more cost-effective, this potential is being jeopardized by “the stifling regulatory environment that is driving medical research abroad,” the Academy warned the politicians.

“The UK has historically supported vibrant research-intensive medical science industries as part of its knowledge economy; however, commercial research activity is moving abroad where there is less burdensome regulation and more incentives,” said Academy president Professor Sir John Bell, and he called for immediate decisive action “to attract and anchor increasingly mobile medical researchers and life science industries in the UK.”

The Academy working group conducting the review, chaired by Professor Sir Michael Rawlins, met for the first time on May 18 and issued a first call for evidence which closed in June. Then on July 26, in the wake of the NHS White Paper, the Department of Health published the results of its review of arm’s-length bodies (ALB) in the health and social care sector, and the Academy is now seeking evidence relating to the proposals contained within the ALB report.

Specifically, the report notes that a number of different ALB currently have responsibility for different aspects of research regulation, including giving permissions. “There is a strong argument for rationalising this and creating greater strategic coherence around research by placing responsibility for these different aspects of medical research regulation within one arm’s-length body that would perform a stand-alone technical function as a research regulator. This would streamline the process of gaining permission to undertake medical research, making it more attractive to universities and health institutions. Moreover, there is potential for a single research regulator to have wider cross-government reach,” says the Department.

In light of the Academy’s review, the report goes on, “we will consider legislation affecting medical research, and the bureaucracy that flows from it, and bring forward plans for radical simplification.”

The Academy is calling for the submission of written evidence by August 31 at 5pm. If respondents cannot meet this deadline, they should let it know, by that date, that they intend submitting evidence, highlighting the substantive issues that they wish to raise, and present their evidence by no later than 5pm on September 14 at 5pm.